Efficacy and Safety of Once-Daily Minoxidil Foam 5% Versus Twice-Daily Minoxidil Solution 2% in Female Pattern Hair Loss: A Phase III, Randomized, Investigator-Blinded Study

    July 2016 in “ PubMed
    Ulrike Blume-Peytavi, Jerry Shapiro, Andrew G. Messenger, Maria K. Hordinsky, Paul J. Zhang, Carlos Quiza, Uday Doshi, Elise A. Olsen
    TLDR Once-daily 5% minoxidil foam and twice-daily 2% minoxidil solution are similarly effective and safe for female pattern hair loss.
    The study compared the efficacy and safety of once-daily 5% minoxidil topical foam (MTF) to twice-daily 2% minoxidil topical solution (MTS) in treating female pattern hair loss. In a randomized, phase III trial involving 322 women, the primary endpoint was the change in target area hair count (TAHC) at 24 weeks. Results showed that 5% MTF increased TAHC by 23.9 ± 2.1 hairs/cm², while 2% MTS increased TAHC by 24.2 ± 2.1 hairs/cm². The treatment difference was -0.3 hairs/cm², with a 95% confidence interval of -6.0 to 5.4, failing to meet the noninferiority criteria. Both treatments were well tolerated, but the noninferiority goal was not achieved.
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